Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer

Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.

This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.

Study Overview

• Status: Unknown
• Conditions: Locally Advanced Pancreatic Cancer
• Intervention / Treatment: Drug: Nab-paclitaxel and S-1

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: YueJuan Cheng; Phone Number: 861069158315; Email: cnchengyuejuan@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients have good compliance, can understand the research process of this study, and sign a written informed consent
2. Patients with pathologically confirmed pancreatic adenocarcinoma.
3. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
4. Patients with locally advanced pancreatic cancer ( NCCN Version 1，2019 criteria).
5. ECOG PS 0-1;
6. Tumor size is measurable according to RECIST1.1 criteria
7. Expected survival over 3 months;
8. Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
9. Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
10. No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion Criteria:

1. ≥ Grade 2 existing peripheral neuropathy;
2. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.

4. Severe, active co-morbidity, defined as follows:

   Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.

5. Not able to take medicine orally.
6. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
7. Participation in other clinical trial within 30 days before the first dose of the drug;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: nab-paclitaxel and S-1; chemotherapy of Nab-Paclitaxel and S-1, repeat 21 days for up to 8 cycles. The following treatment including pancreatectomy, continuing same chemotherapy, S-1 maintenance therapy, or radiotherapy will be decided after discussion between physicians and patients.	Drug: Nab-paclitaxel and S-1; Nab-paclitaxel: 120 mg/m2 d1, 8, S-1:Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 , < 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month progression-free survival (PFS)	The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).	From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 8, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: HS-1751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No